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Innovation in Pulmonary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123422
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : October 7, 2014
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
The purpose of this study was to compare the effect of exercise treatment combined with breathing retraining (a computerized feedback program), with exercise treatment combined with heliox (a helium and oxygen combination), with exercise only in patients with moderate to severe chronic obstructive pulmonary disease. This was an 8-week intervention study.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Pulmonary Emphysema Behavioral: Breathing retraining Behavioral: Heliox Behavioral: Exercise Not Applicable

Detailed Description:

Dynamic hyperinflation limits exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Recently, several innovative approaches have been developed to reduce the burden of dynamic hyperinflation. Two such innovations, ventilation-feedback training and Heliox supplementation during exercise show great promise and posit a reduction in dynamic hyperinflation as a key to their effectiveness. In our recently completed trial, when age, FEV1 and RV/TLC were controlled, exercise plus VF (E+VF) was superior to E training alone (E only) or VF training alone in improving exercise tolerance. The mechanism responsible for this difference was, in part, a reduction in exercise-induced dynamic hyperinflation secondary to a change in breathing pattern. In additional preliminary studies, we determined that exercise tolerance can be increased when patients exercise while inhaling Heliox. Similar to VF, the mechanism for exercise improvement with Heliox was a reduction in exercise-induced dynamic hyperinflation. Although both interventions are promising, there are no definitive data to support use of either intervention as a standard of care for pulmonary rehabilitation.

Hypothesis/Research Questions Overview: The two primary hypotheses are that patients with moderate-severe COPD who successfully complete eight weeks of (a) E+VF training will achieve longer exercise duration than patients randomly assigned to E only and (b) E+heliox training will achieve longer exercise duration than patients randomly assigned to E only.

Methods: This study was a randomized controlled clinical trial. After baseline testing is completed, 103 subjects with moderate-severe COPD were randomized into one of three groups: E+VF, E+Heliox and E training only. Follow-up testing was completed at 8 weeks. testing, activity monitoring, and dyspnea measurements. After baseline testing was completed, randomized subjects trained in the Physical Performance Laboratory three times weekly. Exercise prescriptions were standardized and based on data from the exercise stress test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovation Methods to Augment Pulmonary Rehabilitation
Study Start Date : October 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Breathing retraining
Exercise training with computerized training program
Behavioral: Breathing retraining
exercise training with computerized training program

Experimental: Heliox
Exercise training with helium oxygen combination
Behavioral: Heliox
exercise training with a helium oxygen combination

Active Comparator: Exercise
Exercise training
Behavioral: Exercise
exercise training

Primary Outcome Measures :
  1. Exercise Endurance [ Time Frame: 14 weeks ]
    Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.

Secondary Outcome Measures :
  1. Inspiratory Capacity [ Time Frame: 14 weeks ]
    Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40 years of age
  • FEV1 70%
  • FEV1/FVC <70%
  • RV/TLC > 120%

Exclusion Criteria:

  • Respiratory infection/exacerbation within last 4 weeks
  • Exercise limiting heart disease
  • Primary asthma
  • Congestive heart failure New York Heart Association (NYHA) Class III-IV
  • Exercise limiting peripheral arterial disease or arthritis
  • Inability to walk on a treadmill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123422

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United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Eileen G. Collins, PhD RN Edward Hines Jr. VA Hospital
Publications of Results:
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Responsible Party: US Department of Veterans Affairs Identifier: NCT00123422    
Other Study ID Numbers: F3845-R
First Posted: July 22, 2005    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Breathing exercise
Exercise Therapy
Oxygen inhalation therapy
Pulmonary emphysema
Pulmonary ventilation
Additional relevant MeSH terms:
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Pulmonary Emphysema
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive